Manager, Biomarker Operations

Moderna Therapeutics; Cambridge (MA); On-site; USD 109,200 - 174,600; Full time

Benefits offered by this job

Competitive healthcare

Well-being program

Family planning benefits

Generous paid time off

Discretionary equity/bonus potential

Job summary

Moderna is seeking a seasoned professional to independently support clinical biomarker sample management in trials. You will lead reviews of biomarker sections in protocols and consent forms, and drive central lab database specifications, sample handling, shipment, and reporting across the clinical lifecycle.

Strong knowledge of GCP/ICH, excellent communication, multitasking skills, and proficiency with Excel are essential.

Qualifications

• Bachelor’s degree in a life science-based subject; advanced degree preferred.
• Minimum of 5 years of clinical research experience including sponsor experience.
• Direct experience with clinical sample management.
• Familiarity with Excel is essential.
• Solid understanding of GCP/ICH is required.
• Strong communication skills and attention to detail.
• Demonstrated ability to multitask.

Responsibilities

• Support implementation of clinical biomarker sample management plans and deliverables in Moderna trials.
• Lead review of biomarker sections of protocols, lab manuals and consent forms.
• Lead central lab database specification finalization, including sample kit development, storage, shipment, testing and reporting.
• Track and manage clinical sample lifecycle from collection to long-term storage.
• Monitor clinical sample quality issues and implement resolutions.
• Ensure biosample usage complies with informed consent and GCP/ICH requirements.
• Participate in clinical assay vendor oversight, attend meetings and manage sample shipments.
• Promote process improvements for clinical sample lifecycle.
• Lead development of processes for standardized language, biomarker usage, and data reporting.

Skills

Communication skills

Attention to detail

Multitasking

GCP/ICH knowledge

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

Excel

Job description

Responsibilities

• Independently support the implementation of clinical biomarker sample management plans and deliverables in Moderna clinical trials.
• Lead the review of biomarker sections of clinical protocols, lab manuals and consent forms.
• Lead central lab database specification finalization, including clinical sample kit development, sample storage, sample shipment, sample testing and reporting.
• Track and manage clinical sample lifecycle processes from sample collection to long‑term storage.
• Monitor clinical sample quality issues and implement issue resolutions.
• Support clinical teams to ensure biosample usage is compliant with informed consent and GCP/ICH requirements.
• Participate in clinical assay vendor oversight, attending meetings, addressing sample issues, and requesting sample shipments.
• Promote process improvements for clinical sample lifecycle.
• Lead the development of processes and procedures for standardized language, biomarker usage, and data reporting.

Basic Qualifications

• Bachelor’s degree in a life science‑based subject; advanced degree preferred.
• Minimum of 5 years of clinical research experience which must include sponsor experience.
• Direct experience with clinical sample management.
• Familiarity with Excel is essential.
• Solid understanding of GCP/ICH is required.
• Strong communication skills and attention to detail.
• Demonstrated ability to multitask.

Pay & Benefits

The salary range for this role is $109,200.00 – $174,600.00.

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

• Competitive healthcare, plus voluntary benefit programs.
• A holistic approach to well‑being, with access to fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
• Savings and investments to help you plan for the future.
• Location‑specific perks and extras.

Equal Opportunity & Accommodations

Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E‑Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position should contact the Accommodations team at [e-mail].